OM1 Registry Center of Excellence

Dr. Rich Gliklich is Founder of OM1, an outcomes and technology company focused on using deep clinical data and advanced analytics to measure and predict health outcomes for real-world evidence and value-based care. Rich was Founder and CEO of Outcome Sciences, a registries and comparative effectiveness company that served more than 2500 healthcare organizations and a majority of the global top 30 life sciences companies. Rich led Outcome for 13 years through its acquisition by Quintiles in 2011 and then stayed on at Quintiles through its 2013 IPO. After that, Rich joined General Catalyst Partners as an XIR focused on investments in healthcare companies until founding OM1 in 2015. 

Rich is PI and senior editor of the Agency for Healthcare Research and Quality (AHRQ)’s Registries for Evaluating Patient Outcomes: A User’s Guide, 1st - 4th editions. This is the worldwide reference document for understanding quality in real-world studies and registries. Rich is leading a U.S. government-funded effort to standardize health outcomes measurement across and within conditions called the Outcomes Measures Framework. Stakeholders for that effort include HHS, FDA, CMS, NIH, specialty societies, payers, and patient advocacy organizations. Rich holds patents in medical outcomes systems and devices, and multiple applications around the use of AI with medical data for real-world evidence and personalized healthcare.

Michelle Leavy, MPH, is the Senior Director, Registries at OM1, where she oversees prospective observational studies and patient registries as well as projects related to improving patient registry methodology and harmonizing data and outcome measures across patient registries and clinical practice. Michelle was the managing editor of Registries for Evaluating Patient Outcomes: A User’s Guide, and she led a federally funded effort to harmonize outcome measures across registries and clinical care to support depression research. She previously managed efforts to develop harmonized outcome measures for use in patient registries under the Outcome Measures Framework (OMF) project. At OM1, she leads the Registry Center of Excellence, which provides internal and external consulting on observational study best practices. Michelle is a graduate of Columbia College and the UNC Gillings School of Global Public Health. Ms. Leavy is a recognized international expert in registry and longitudinal study design and operations.

Ombretta Palucci is Vice President and Head of Operations, Europe at OM1. Based in Switzerland, she is a pharmaceutical scientist with more than 20 years of leadership in real-world evidence, registries, post-marketing studies, and observational research across Europe. Ombretta brings deep expertise in designing and operationalizing complex registries and has significant experience in global and multi-country studies. Previously, at IQVIA and PAREXEL, she led solution design and delivery for large-scale real-world programs, including oversight of observational studies, pragmatic trials, safety surveillance, and registries. She has extensive experience in global study operations covering regulatory submissions, CRO and vendor management, site activation, patient enrollment, and ethics approvals. She has also managed international teams of up to 100 staff, leading budgets, client engagements, proposal defenses, and business development initiatives. Ombretta holds a Master’s Degree in Pharmaceutical Chemistry and Technology (110/110 cum laude) from the Università degli Studi, Siena, Italy.